CardioMetabolic Program Meets eHealth: Redesign and Evaluation for Optimal Reach and Impact

Not Applicable

Completed

• Conditions: Type 2 Diabetes; Obesity; Metabolic Syndrome; Pre-diabetes; Cardiovascular Disease
• Interventions: Behavioral: eCMP

• Registration Number: NCT02246400
• Lead Sponsor: Palo Alto Medical Foundation

Brief Summary

The eCMP Pilot aims to study the feasibility and potential effectiveness of an electronically-mediated CardioMetabolic Program (eCMP) for therapeutic lifestyle change among adults with or at high risk for type 2 diabetes, heart disease, and/or stroke.

Detailed Description

The eCMP is an evidence-based lifestyle intervention using a holistic, mind-body-spirit-based, and multidisciplinary approach, and it will be delivered using existing web and mobile technologies. In this pragmatic randomized controlled trial, participants will be recruited from primary care patients of an integrated ambulatory care system. They will be randomly assigned to receive the eCMP upon completion of baseline data collection (the Immediate Intervention group) or after 3 months (the Delayed Intervention group). All participants will be assessed at 0, 3 and 6 months. Outcomes include common cardiometabolic risk factors (e.g., weight, blood pressure, and fasting plasma glucose), health behaviors (e.g., dietary intake and physical activity), and indicators of eCMP engagement and adherence (e.g., attendance and self-monitoring).

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-09-18
• Study First Posted: 2014-09-22
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-29
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• English-speaking adults aged 18+ years
• High-risk primary prevention: BMI 35+ and prediabetes (including hx of gestational diabetes) and/or metabolic syndrome
• Secondary prevention: BMI 30+ and type 2 diabetes and/or cardiovascular disease
• Able and willing to provide written informed consent

Exclusion Criteria

• Medical determination that the study is inappropriate or unsafe for the patient
• Type 1 diabetes
• Safety concerns related to significant physical or mental health issues or life expectancy of less than 12 months
• Currently pregnant or lactating
• No regular telephone or broadband Internet access or otherwise unable to participate in the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate Intervention	eCMP	Initiation of the eCMP immediately upon completion of baseline data collection and randomization
Delayed Intervention	eCMP	Usual care for first three months. Initiation of the eCMP after the 3-month time point.

Primary Outcome Measures

Name	Time	Method
Change in measure of Health-related quality of life from baseline to 6-months follow up.	6-months	SF-8 questionnaire

Secondary Outcome Measures

Name	Time	Method
Change in composite measure of Metabolic Syndrome	6-months.	Composite measure of Metabolic Syndrome (criterion factors: waist circumference, blood pressure, fasting plasma glucose, triglycerides, High-density lipoprotein, and body mass index.)
Dietary Intake	Baseline, 3-months, and 6-months.	Nutrition Data System for Research (NDSR).
Intervention adherence	3-months and 6-months.	Intervention session attendance of virtual classes and in-person physical activity classes.
Body weight	Baseline, 3 months, and 6 months
Physical Activity	Baseline, 3-months, and 6-months.	Seven-Day Physical Activity Recall (PAR).

Trial Locations

Locations (1)

Palo Alto Medical Foundation, Mills Peninsula Division; 🇺🇸 Burlingame, California, United States